Kidney Transplantation Clinical Trial
Official title:
Pilot Study Using Donor Stem Cells and Campath-1H to Induce Renal Transplant Tolerance (ITN022ST)
Alemtuzumab is a man-made antibody used to treat certain blood disorders. This study will evaluate treatment of kidney transplant recipients with alemtuzumab and other immune system suppressing medications with or without infusions of bone marrow stem cells from the kidney donor. The purpose of this study is to find out which strategy is more effective in preventing organ rejection and maintaining patient health.
Organ transplantation is a common procedure in hospitals, but organ rejection and serious
side effects are potential problems for the patient. Mycophenolate mofetil, sirolimus, and
tacrolimus are drugs used to decrease immune system activity in people who have received
organ transplants so that the new organ will not be rejected. Alemtuzumab is a monoclonal
antibody that binds to and depletes excess T cells in the bone marrow of leukemia patients.
In this study, alemtuzumab will be used to destroy the recipient's white blood cells (WBCs)
at the time of transplantation. It is hoped that WBCs produced after alemtuzumab
administration will recognize the transplanted liver as "self" and will not attack the new
kidney.
To further assist the immune system in accepting the donor kidney, some patients in this
study will also receive two infusions of bone marrow stem cells from the kidney donor. Bone
marrow stem cells are adult blood cells from which other specialized blood cells, such as T
cells, develop. Treatment with these cells is believed to create a state of "chimerism" in
the body, where the immune cells of both the donor and recipient can coexist and tolerate
the presence of a donor organ. This study will evaluate the safety and effectiveness of an
antirejection regimen including alemtuzumab and other immunosuppressive medications and
donor bone marrow stem cell infusions in patients undergoing kidney transplantation.
This study will last 3 years. Participants will be randomly assigned to receive either the
full immunosuppressive therapy and donor bone marrow stem cell infusions (Group 1) or
immunosuppressive therapy alone (Group 2). Patients will undergo kidney transplantation at
the start of the study on Day 0. Patients will receive inpatient infusions of alemtuzumab on
Days 0 and 4. Starting on Day 0, patients will begin taking mycophenolate mofetil; starting
on Day 1, patients will also begin taking tacrolimus. On Day 5, patients in Group 1 will
receive their first of 2 infusions of purified stem cells taken from the kidney donor's bone
marrow; their second infusion of stem cells will occur sometime between Months 4 and 6
post-transplant.
Beginning between Months 4 and 6 post-transplant, all participants will begin receiving
low-dose maintenance immunosuppressive therapy with sirolimus, as is typical for
post-transplant antirejection therapy. One year post-transplant, patients will be evaluated
for the potential to withdraw some or all of this maintenance immunotherapy. Participants
will be monitored for 3 years post-transplant. Urine collection will occur at Week 1 and
Months 1, 3, 6, and 9. At Months 12, 24, and 30, participants will undergo kidney biopsies.
Blood collection will occur at regular intervals for laboratory tests to evaluate the immune
system's response to the transplanted kidney.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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